Improving Behavioral Health Care for Children With ADHD

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Behavioral: Behavioral Parent Training (BPT)

• Registration Number: NCT02972086
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC) Model. The IPFAC is intended to increase access to evidence-based behavioral parent training (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD) who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of Developmental and Behavioral Pediatrics.

Detailed Description

The specific aims of this study are to: 1) Develop the IPFAC model (Phase I); 2) Assess and determine facilitators and barriers to fidelity, assess feasibility of data acquisition, determine preliminary efficacy, and refine the IPFAC model through a small-scale implementation study and Plan-Do-Study-Act methods (Phase II), and, 3) Evaluate the revised IPFAC model in a small-scale study using state-of-the-art single-case study design methods/analyses to test "treatment mechanisms" in a sample of newly diagnosed youth with ADHD (Phase III) and finalize the IPFAC procedural manual.

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Study Start: 2017-01-07
• Primary Completion: 2017-08-07
• Study Completion: 2017-08-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• being a parent of a child who is a patient at the NYU Bellevue ADHD Clinic
• being an adult over the age of 18
• having a child who obtained a diagnosis of ADHD (any subtype) within the previous 3 months (ie.., newly diagnosed) through the NYU Bellevue ADHD Clinic
• parent must speak English and/or Spanish.

The second study participant is the child. Study inclusion criteria for children include:

• child is a patient at the NYU Bellevue ADHD Clinic
• child is between the age of 6-11
• participating child must have obtained a diagnosis of ADHD (any subtype) within the previous 3 months (i.e., newly diagnosed) through the NYU Bellevue ADHD Clinic,
• child must speak English and/or Spanish.

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Exclusion Criteria

• parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
• child with primary diagnosis/presenting issues of severe mental illness (e.g., schizophrenia; bipolar disorder) that would warrant primary services other than what is offered through the project.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parent	Behavioral Parent Training (BPT)	Parent of a child who is a patient at the NYU Bellevue Attention Deficit Hyperactivity Disorder (ADHD) Clinic

Primary Outcome Measures

Name	Time	Method
Attendance at BPT sessions	16 Weeks	Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.
Parenting Behavior	16 Weeks	The Alabama Parenting Questionnaire- Short Form (APQ-SF) is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting, inconsistent discipline and poor supervision.
ADHD and oppositional behavior will be measured by the IOWA Connors Rating Scale (IOWA-CRS)	16 Weeks	The IOWA-CRS (Waschbusch \& Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).
Parental Depressive Symptoms using Beck Depression Inventory-II	16 Weeks	a 21-item self-report measure used to assess maternal depressive symptoms. Mothers were instructed to indicate which of four statements best described how they felt over the preceding two week period. The BDI is scored from one to four, with higher scores on the BDI indicating a greater degree of depression. A total score on the BDI, which is a sum of the 21-item measure, will be used in the study.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States